Methods And Compositions For Medical Articles Produced From Proteinaceous Compounds

Abstract

The invention disclosed herein provides compositions and methods for biocompatible biomaterials with improved control of microorganisms, improved biocompatibility, lower toxicity, and reduce vCJD transmission potential. These combined benefits cascade to provide improved efficacy, improved patient compliance and improved performance, while limiting clinical complications in treatment.

We claim: 
     
         1 . A solidified foam composition useful as a tissue sealant, tissue dressing, hemostatic sponge or tissue barrier comprising: lactoferrin, derivatives thereof, and any combination thereof crosslinked to solidify the structure. 
     
     
         2 . The composition of  claim 1  further comprising a secondary component selected from the group of: (a) an augmentative polymer, monomer, or compound with reactive groups, (b) an adjunct compound; (c) an anti-infective; (d) a crosslink augmentation agent; (e) a crosslinking-agent, and any combination thereof. 
     
     
         3 . The composition of  claim 2  wherein the augmentative polymer, monomer or compound contains reactive sites selected from the group of a nitrogen containing site, a sulfur containing site, or any combination thereof. 
     
     
         4 . The composition of  claim 2  wherein the adjunctive compound is selected from the group of surfactants, antioxidants, fatty acids, polyvinylpyrrolidone, polyvinyl alcohol, hydrogen peroxide, poly(ethylene glycol), carrageenen, alginates, and any combination thereof. 
     
     
         5 . The composition of  claim 2  wherein the anti-infective is selected from the group of urea, a lipid compound or compounds, fatty acids, a silver compound, lysozyme, sulfonamide, sulfamethoxazole, a sugar, a sugar alcohol, xylitol, methylene blue, gentian violet, an aminoglycoside, tetracyclines, macrolides, glycopeptides, lipoglycopeptides, beta lactams, quinolones, and any combination thereof. 
     
     
         6 . The composition of  claim 2  wherein the crosslinking-agent is selected from the group consisting of an aldehyde compound, a polyaldehyde compound, formaldehyde, glutaraldehyde, acetaldehyde, malonaldehyde, succinaldehyde, adipaldehyde, dialdehyde starch, glyoxal, glyoxylic acid, adipyldichloride, acrolein, N,N′-methylenebisacrylamide, diphenylphosphoryl azide, N,N′-ethylenebisacrylamide, diphenylphosphoryl azide, (poly)ethylene glycol di(meth)acrylate, functionalized (poly)ethylene glycol derivatives, ethylene glycol diglycidyl ether, glycidylmethacrylate, polyamidoamineepichlorohydrin, trimethylolpropanetriacrylate, piperazinediacrylamide, epichlorohydrin, 1,2-diol compounds, tannins, and any combination thereof. 
     
     
         7 . The composition of  claim 2  wherein the crosslink augmentation agent is selected from the group of polyamine compounds, polyhydroxybenzene, resorcinol, vanillin, urea, nicotinamide, adenosine, carbodiimide, cyanamide, and any combination thereof. 
     
     
         8 . A method of producing a solidified foam useful as a tissue sealant, tissue dressing, hemostatic sponge or tissue barrier comprising: (a) dissolving lactoferrin, derivatives thereof, and any combination thereof, (b) mixing the dissolved material with at least one gas vigorously, including by homogenization, and (c) subsequently adding a crosslinking-agent to crosslink reactive sites of the composition thereby producing the desired solidified foam. 
     
     
         9 . A method of producing a solidified multiparticulate composition useful as a biomaterial device, tissue implant and wound dressing comprising: combining (a) lactoferrin, derivatives thereof, and any combination thereof, and (b) a secondary component selected from the group of: (i) an augmentative polymer, monomer, or compound with reactive groups, (ii) an adjunct compound, (iii) an anti-infective, (iv) a crosslink augmentation agent and any combination thereof, and (c) adding a crosslinking-agent to solidify the composition for production of multiparticulates.